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    Summary
    EudraCT Number:2015-000162-59
    Sponsor's Protocol Code Number:PHRCN2014DURIF
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-06-03
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2015-000162-59
    A.3Full title of the trial
    Evaluation of botulinum toxin injection efficacy in the treatment of head essential tremor by a multi-center, randomized, double–blind, parallel-group, placebo-controlled study
    Evaluation de l’efficacité d’injections de toxine botulinique dans le traitement du tremblement du chef par une étude multicentrique, randomisée, en double aveugle, en groupe parallèle, contrôlée versus placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of botulinum toxin injection efficacy in the treatment of head essential tremor
    Evaluation de l’efficacité d’injections de toxine botulinique dans le traitement du tremblement du chef
    A.3.2Name or abbreviated title of the trial where available
    Btx-HT
    Btx-HT
    A.4.1Sponsor's protocol code numberPHRCN2014DURIF
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU Clermont-Ferrand
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPHRC National
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Clermont-Ferrand
    B.5.2Functional name of contact pointPatrick Lacarin
    B.5.3 Address:
    B.5.3.1Street AddressDRCI, 58 rue Montalembert
    B.5.3.2Town/ cityClermont-Ferrand
    B.5.3.3Post code63000
    B.5.3.4CountryFrance
    B.5.4Telephone number+33473 751 195
    B.5.5Fax number+33473 754 730
    B.5.6E-mailplacarin@chu-clermontferrand.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name BOTOX
    D.2.1.1.2Name of the Marketing Authorisation holderALLERGAN
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBOTOX
    D.3.4Pharmaceutical form Powder for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 93384-43-1
    D.3.9.3Other descriptive nameBOTULINUM TOXIN TYPE A
    D.3.9.4EV Substance CodeSUB13117MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number300 to 350
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients présentant un tremblement essentiel du chef
    E.1.1.1Medical condition in easily understood language
    Patients présentant un tremblement essentiel du chef
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Montrer l’effet bénéfique d’injections intramusculaires de toxine botulinique dans le contrôle du tremblement essentiel du chef.
    E.2.2Secondary objectives of the trial
    - Evaluer la tolérance des patients à ce traitement.
    - Evaluer l’impact d’un traitement par toxine botulinique sur la qualité de vie et la gêne ressentie par des patients présentant un TE du chef.
    - Evaluer les modifications des caractéristiques du tremblement engendrées par un traitement par toxine botulinique en utilisant un accéléromètre (fréquence, amplitude, distance parcourue…) et un nouveau système vidéo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients souffrant d’un TE du chef isolé ou avec un tremblement associé (autre partie du corps). La sévérité évaluée par la Fahn-Tolosa-Marin Tremor Rating Scale (TRS) doit être >1 pour l’item tremblement de la tête.
    - Patients jamais traités pat toxine botulinique.
    - Patients des deux sexes âgés de 18 à 80 ans.
    - Patients affiliés à un régime de sécurité sociale.
    - Patients volontaires ayant donné leur consentement écrit.
    E.4Principal exclusion criteria
    - Patients présentant un tremblement du chef avec une composante dystonique et/ou myoclonique significative (Tsui scale >0).
    - Patients présentant des tremblements dus à un syndrome cérébelleux
    - Les traitements oraux utilisés pour le TE sont autorisés mais doivent être stables pendant toute la durée de l’étude.
    - Patients présentant des « contre-indications » à l’utilisation de la toxine botulinique : allergie à l’un des composants, myasthénie, allaitement, grossesse, utilisation d’aminosides.
    - Femmes sans contraception efficace pour les femmes en âge de procréer
    - Patients sous tutelle ou curatelle ou sauvegarde de justice.
    - Patients en période d’exclusion d’une autre étude.
    E.5 End points
    E.5.1Primary end point(s)
    Le critère d’évaluation principal sera l’amélioration de l’état clinique du patient consécutive au traitement grâce à l’échelle CGI (Clinical Global Impression Change), mesurée 6 semaines après la 2ième série d’injections (J+18sem).
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 semaines après la 2ième série d'injection (à J+18 semaines)
    E.5.2Secondary end point(s)
    - % de répondeurs (défini à partir de la CGI) à chaque temps d’évaluation
    - Evaluation du tremblement : the Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sous item Tête).
    - Evaluation de la gêne : the Essential Tremor Embarrassment Assessment (ETEA).
    - Evaluation de la qualité de vie : The Quality of life in Essential Tremor (QUEST).
    - Evaluation qualitative et quantitative du tremblement par accélérométrie (mesure de la fréquence, de l’amplitude, de la distance parcourue…) et en utilisant un système vidéo (mesure du déplacement en voxel).
    E.5.2.1Timepoint(s) of evaluation of this end point
    J0, J+6sem, J+12sem, J+18sem, J+24sem
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned13
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Dernière visite de la dernière personne participant à l'essai
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months21
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-13
    P. End of Trial
    P.End of Trial StatusOngoing
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